Abstract
To review selective health outcome measures for diabetes mellitus focussing on psychometric properties. Systematic literature search was carried out to identify the instruments using electronic databases and manual search from relevant journals. Health outcome measures were assessed with predefined inclusion and exclusion criteria. Each instrument was assessed for patient related information, instrument content, reliability, validity and responsiveness to change. The electronic and manual search generated 317 relevant references. Twenty seven instruments that met the inclusion criteria were included in the study. Among the 27 instruments, 20 were in English language. Out of these, 14 instruments were developed in USA and the majority of the remaining in UK. The time taken to complete the questionnaires varied from 3-40 minutes. Appraisal of Diabetes Scale and Audit of Diabetes-Dependent Quality of Life are single index instruments and the remaining instruments have dimension in a range of three to nine. Appraisal of Diabetes Scale and Diabetes Treatment Satisfaction Questionnaire are the shortest questionnaire whereas Diabetes Care Profile is the longest. The Diabetes Treatment Satisfaction Questionnaire has more translations followed by Diabetes Medication Satisfaction, Audit of Diabetes-Dependent Quality of Life, Diabetes Health profile, Problem area in diabetes scale and Insulin Treatment Appraisal Scale. All the instruments were assessed for psychometric properties. The Diabetes Care Profile, Diabetes-39, Diabetes Quality of life measure, Diabetes specific Quality of life scale, Diabetes Treatment Satisfaction Questionnaire, Diabetes symptom checklist-Revised and Diabetes Medication Satisfaction instruments have good psychometric properties and may be useful for the researcher interested in diabetes care. Most of the instruments were lacking in responsiveness evaluation and were developed and evaluated mainly in developed countries. There is a need, therefore, to focus future research on health outcome measures on the evaluation of responsiveness.
Similar content being viewed by others
References
Aaronson, N., Alonso, J., Burnam, A., Kathleen, N. L., Patrick, D. L., Perrin, E., & Ruth, E. K. S. (2002). Assessing health status and quality-of-life instruments: attributes and review criteria. Quality of Life Research, 11, 193–205.
Amiel, S., Beveridge, S., Bradley, C., Gianfrancesco, C., Heller, S., James, P., McKeown, N., et al. (2002). Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE) randomised controlled trial. BMJ, 325, 746–749.
Anderson, R. T., Skovlund, S. E., Marrero, D., Levine, D. W., Meadows, K., Brod, M., & Balkrishnan, R. (2004). Development and validation of the insulin treatment satisfaction questionnaire. Clinical Therapeutics, 26(4), 565–578.
Anderson, R. T., Girman, C. J., Camacho, F. T., Pawaskar, M. D., Calles, J., Kelly, W. S., DeMuro, C., & Balkrishnan, R. (2009). Diabetes medication satisfaction tool: a focus on treatment regimens. Diabetes Care, 32, 51–53.
Araki, A., & Ito, H. (2003). Development of elderly diabetes burden scale for elderly patients with diabetes mellitus. Geriatrics and Gerontology International, 3, 212–222.
Arbuckle, R. A., Humphrey, L., Vardeva, K., Arondekar, B., Danten-Viala, M., Scott, J. A., & Snoek, F. J. (2009). Psychometric evaluation of the Diabetes Symptom Checklist-Revised (DSC-R)-a measure of symptom distress. Value in health, 12(8), 1168–1175.v.
Beaser, R. S., Garbus, S. B., & Jacobson, A. M. (1996). Diabetes mellitus. In: B. Spilker (Ed.) Quality of life in clinical trials, 2nd edn. Philadelphia: Lippincott-Raven, 102, 983–992
Bott, U., Muhlhauser, I., Overmann, H., & Berger, M. (1998). Validation of a diabetes-specific quality-of-life scale for patients with type 1 diabetes. Diabetes Care, 21, 757–769.
Bott, U., Ebrahim, S., Hirschberger, S., & Scovlund, S. E. (2003). Effect of rapid-acting insulin analogue insulin aspart on quality of life and treatment satisfaction in patients with type 1 diabetes. Diabetic Medicine, 20, 626–634.
Bowling, A. (1997). Measuring health: A review of quality of life measurement scales (2nd ed.). Buckingham: Open University Press.
Boyer, J. G., & Earp, J. A. L. (1997). The development of an instrument for assessing the quality of life of people with diabetes: diabetes-39. Medical Care, 35, 440–453.
Bradley, C., Todd, C., Gorton, T., Symonds, E., Martin, A., & Plowright, R. (1999). The development of an individualized questionnaire measure of perceived impact of diabetes on quality of life: the ADDQoL. Quality of Life Research, 8, 79–91.
Bradley, C., Plowright, R., Stewart, J., Valentine, J., & Witthaus, E. (2007). The Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) evaluated in insulin glargine trials shows greater responsiveness to improvements than the original DTSQ. Health and Quality of Life Outcomes, 5, 57.
Brod, M., Christensen, T., Kongsø, J. H., & Bushnell, D. M. (2009). Examining and interpreting responsiveness of the Diabetes Medication Satisfaction measure. Journal of Medical Economics, 12(4), 309–316.
Cappelleri, J. C., Gerber, R. A., Kourides, I. A., & Gelfand, R. A. (2000). Development and factor analysis of a questionnaire to measure patient satisfaction with injected and inhaled insulin for type 1 diabetes. Diabetes Care, 23, 1799–1803.
Carey, M. P., Jorgensen, R. S., Weinstock, R. S., Sprafkin, R. P., Lantinga, L. J., Carnrike, C. L. M., et al. (1991). Reliability and validity of the appraisal of diabetes scale. Journal of Behavioral Medicine, 14, 43–51.
Cheng, A. Y., Tsui, E. Y., Hanley, A. J. G., & Zinman, B. (1999). Developing a quality of life measure for Chinese patients with diabetes. Diabetes Research and Clinical Practice, 46, 259–267.
Cohen, J. (1977). Statistical power analysis for the behavioural sciences. New York: Academic.
Cook, D. A., & Beckman, T. J. (2006). Current concepts in validity and reliability for psychometric instruments: theory and application. The American Journal of Medicine, 119, 166.e7–166.16.
Costa, F. A., Guerreiro, J. P., & Duggan, C. (2006). An audit of diabetes dependent quality of life (ADDQoL) for Portugal: exploring validity and reliability. Pharmacy Practice, 4, 123–128.
Cunningham, V., Mohler, M. J., Wendel, C. S., Hoffman, R. M., Murata, G. H., Shah, J. H., et al. (2005). Reliability and validity of the DCP among hispanic veterans. Evaluation & the Health Professions, 28, 447–463.
David, R. W., Leonor, G., Clara, W., & Jonathan, S. (2011). IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Research and Clinical Practice, 94(3), 311–321.
Davies, M. J., Heller, S., Skinner, T. C., Campbell, M. J., Carey, M. E., Cradock, S., et al. (2008). Effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cluster randomised controlled trial. BMJ, 336(7642), 491–495.
De Groot, M., Anderson, R., Freedland, K. E., Clouse, R. E., & Lustman, P. J. (2001). Association of depression and diabetes complications: a meta-analysis. Psychosomatic Medicine, 63, 619–630.
Diener, E., Suh, E. M., Lucas, R., & Smith, H. L. (1999). Subjective well-being: three decades of progress. Psychological Bulletin, 125(2), 276–302.
Donatti, C., Wild, D., Horblyuk, R., Beusterien, K. M., Anderson, R. T., Arondekar, B., & DiBenedetti, D. B. (2008). Psychometric evaluation of the Satisfaction with Oral Anti-Diabetic Agent Scale (SOADAS). Diabetes Research and Clinical Practice, 80, 108–113.
Duran, G., Herschbach, P., Waadt, S., Strain, F., & Zettler, A. (1995). Assessing daily problem with diabetes: a subject oriented approach to compliance. Psychological Reports, 76, 515–521.
Eiko, S., Yoshimi, S., Mitsunori, M., & Keiko, K. (2004). Development of a diabetes Diet-Related Quality-of-Life Scale. Diabetes Care, 27(6), 1271–1275.
El Achhab, Y., Nejjari, C., Chikri, M., & Lyoussi, B. (2008). Disease-specific health-related quality of life instruments among adults diabetic: a systematic review. Diabetes Research and Clinical Practice, 80, 171–184.
Fizgerald, J. T., Davis, W. K., Connell, C. M., Hess, G. E., Funnell, M. M., & Hiss, R. G. (1996). Development and validation of the Diabetes Care Profile. Evaluation & the Health Professions, 19, 208–230.
Fitzgerald, J. T., Gruppen, L. D., Anderson, R. M., Funnell, M. M., Jacober, S. J., Aman, L. C., et al. (2000). The influence of treatment modality and ethnicity on attitudes in type 2 diabetes. Diabetes Care, 23(3), 313–318.
Fitzpatric, R., Davey, C., Buxton, M. J., & Jones, D. R. (1998). Evaluating patient based outcome measures for use in clinical trial. Health Technology Assessment, 2, 1–74.
Garratt, A. M., Schmidt, L., & Fitzpatrick, R. (2002). Patient assessed health outcome measures for diabetes a structured review. Diabetic Medicine, 19, 1–11.
Goddijn, P., Bilo, H., Meadows, K., Groenier, K., Feskens, E., & Meyboom-de Jong, B. (1996). The validity and reliability of the Diabetes Health Profile (DHP) in NIDDM patients referred for insulin therapy. Quality of Life Research, 5(4), 433–442.
Grootenhuis, P. A., Snoek, F. J., Heine, R. J., & Boutee, L. M. (1994). Development of type 2 diabetes symptom checklist: a measures of symptom severity. Diabetic Medicine, 11, 253–261.
Gross, C. C., Scain, S. F., Scheffel, R., Gross, J. L., & Hutz, C. S. (2007). Brazilian version of the Problem Areas in Diabetes Scale (B-PAID): validation and identification of individuals at high risk for emotional distress. Diabetes Research and Clinical Practice, 76, 455–459.
Guyatt, G. H., Feeny, D. H., & Patrick, D. L. (1993). Measuring health- related quality of life. Annals of Internal Medicine, 118, 622–629.
Hammond, G. S., & Aoki, T. T. (1992). Measurement of Health Status in diabetic patients: diabetes impact measurement scales. Diabetes Care, 15, 469–477.
Hays, R. D., Anderson, R., & Revicki, S. D. (1993). Psychometric considerations in evaluating health-related quality of life measures. Quality of Life Research, 2(6), 441–449.
Hearnshaw, H., Wright, K., Dale, J., Sturt, J., Vermeire, E., & Van Royen, P. (2007). Development and validation of the Diabetes Obstacles Questionnaire (DOQ) to assess obstacles in living with Type 2 diabetes. Diabetic Medicine, 24, 878–882.
Herschbach, P., Duran, G., Waadt, S., Zettler, A., Amm, C., & Marten-Mittag, B. (1997). Psychomentric properties of the questionnaire on stress in patients with diabetes: revised (QSD-R). Health Psychology, 16, 171–174.
Hirsch, A., Bartholomae, C., & Volmer, T. (2000). Dimensions of quality of life in people with non-insulin-dependent diabetes. Quality of Life Research, 9, 207–218.
Huang, I. C., Liu, J. H., Wu, A. W., & Wu, M. Y. (2008). Walter Leite5 and Chyng-Chuang Hwang4. Evaluating the reliability, validity and minimally important difference of the Taiwanese version of the diabetes quality of life (DQOL) measurement. Health and Quality of Life Outcomes, 6, 87.
Husteda, J. A., Cook, B., Farewellc, V. J., & Gladman, D. D. (2000). Methods for assessing responsiveness: a critical review and recommendations. Journal of Clinical Epidemiology, 53, 459–468.
Hwee-Lin, W., Chee-Eng, T., Su-Yen, G., & Shu-Chuen, L. (2006). Usefulness of the Audit of Diabetes-Dependent Quality-of-Life (ADDQoL) Questionnaire in Patients with Diabetes in a Multi-Ethnic Asian Country. PharmacoEconomics, 24(7), 673–682.
International Diabetes Federation. (2011). Diabetes atlas (5th ed.). Brussels: International Diabetes Federation.
Jacobson, A. M. (1997). Quality of life in patients with diabetes mellitus. Seminars in Clinical Neuropsychiatry, 2, 82–93.
Jacobson, A. M. (2004). Impact of improved glycemic control on quality of life in patients with diabetes. Endocrine Practice, 10, 502–508.
Jacobson, A. M., Barofsky, I., Cleary, P., & Rand, L. L. (1988). Reliability and validity of a diabetes quality-of-life measure for the diabetes control and complications trial (DCCT). Diabetes Care, 11, 725–732.
Jacobson, A. M., De Groot, M., & Samson, J. A. (1994). The evaluation of two measures of quality-of-life in patients with Type-I and Type-II diabetes. Diabetes Care, 17, 267–274.
Kazis, L. E., Anderson, J. J., & Meenan, R. F. (1989). Effect sizes for interpreting changes in health status. Medical Care, 27, S178–S189.
Khader, Y. S., Bataineh, S., & Batayha, W. (2008). The Arabic version of Diabetes-39: psychometric properties and validation. Chronic Illness, 4, 257–263.
Kolawolel, B. A., Abodunde, O., Ikem, R. T., & Fabiy, A. K. (2004). A test of the reliability and validity of a diabetes specific quality of life scale in a N’igerian hospital. Quality of Life Research, 13, 1287–1295.
Li, T. C., Lin, C. C., Liu, C. S., Li, C. I., & Lee, Y. D. (2006). Validation of the Chinese version of the diabetes impact measurement scales amongst people suffering from diabetes. Quality of Life Research, 15, 1613–1619.
Magwood, G. S., Zapka, J., & Jenkins, C. (2008). A review of systematic review evaluating diabetes invention: focus on quality of life and disparities. The Diabetes Educator, 34, 242–265.
Mannucci, E., Ricca, V., Bardini, G., & Rotella, C. M. (1996). Well-being enquiry for diabetics: a new measure of diabetes-related quality of life. Diabetes, Nutrition & Metabolism, 9, 89–102.
Meadows, K., Steen, N., McColl, E., Eccles, M., Shiels, C., Hewison, J., et al. (1996). The diabetes health profile (DHP): a new instrument for assessing the psychosocial profile of insulin requiring patients: development and psychometric Evaluation. Quality of Life Research, 5, 242–254.
Meadows, K. A., Abrams, S., & Sandbaek, A. (2000). Adaptation of the Diabetes Health Profile (DHP-1) for use with patients with Type 2 diabetes mellitus: psychometric evaluation and cross-cultural comparison. Diabetic Medicine, 17, 572–580.
Meryl, B., Skovlund, S. E., & Wittrup-Jensen, K. U. (2006). Measuring the impact of diabetes through patient report of treatment satisfaction, productivity and symptom experience. Quality of Life Research, 15, 481–491.
Peyrot, M., & Rubin, R. R. (2005). Validity and reliability of an instrument for assessing health-related quality of life and treatment preferences: the insulin delivery system rating Questionnaire. Diabetes Care, 28, 53–58.
Polonsky, W. H., Anderson, B. J., Lohrer, P. A., Welch, G., Jacobson, A. M., Aponte, J. E., et al. (1995). Assessment of diabetes-related distress. Diabetes Care, 18, 754–760.
Polonsky, W. H., Fisher, L., Earles, J., Dudl, J., Lees, J., Mullan, J., et al. (2005). Assessing psychosocial distress in diabetes: development of the Diabetes Distress Scale. Diabetes Care, 28, 626–631.
Rose, M., Fliege, H., Hildebrandt, M., Schirop, T., & Klapp, B. F. (2002). The network of psychological variables in patients with diabetes and their importance for quality of life and metabolic control. Diabetes Care, 25(1), 35–42.
Shen, W., Kotsanos, J. G., Huster, W. J., Mathias, S. D., Andrejasich, C. M., & Patrick, D. L. (1999). Development and validation of the diabetes quality of life clinical trial questionnaire. Medical Care, 37, AS45–AS66.
Sigurdardottira, A. K., & Benediktsson, R. (2008). Reliability and validity of the Icelandic version of the problem area in diabetes (PAID) scale. International Journal of Nursing Studies, 45, 526–533.
Snoek, F. J. (2000). Quality of life: a closer look at measuring patients’ well-being. Diabetes Spectrum, 13(1), 24–28.
Snoek, F. J., Pouwer, F., Welch, G. W., & Polonsky, W. H. (2000). Diabetes related emotional distress in Dutch and U.S. diabetic patients: cross-cultural validity of the problem areas in diabetes scale. Diabetes Care, 23, 1305–1309.
Snoek, F. J., Skovlund, S. E., & Pouwer, F. (2007). Development and validation of the insulin treatment appraisal scale (ITAS) in patients with type 2 diabetes. Health and Quality of Life Outcomes, 5, 69.
Talbot, F., Nouwen, A., Gingras, J., Gosselin, M., & Audet, J. (1997). The assessment of diabetes-related cognitive and social factors: The Multidimensional Diabetes Questionnaire. Journal of Behavioral Medicine, 20(3), 291–312.
Watkins, K., & Connell, C. M. (2004). Measurement of health-related QOL in diabetes mellitus. PharmacoEconomics, 22(17), 1109–1126.
Welch, G. W., Jacobson, A. M., & Polonsky, W. H. (1997). The problem areas in diabetic scale: an evaluation of its clinical utility. Diabetes Care, 20(5), 760–766.
Yildirim, A., Akinci, F., Gozu, H., Sargin, H., Orbay, E., & Sargin, M. (2007). Translation, cultural adaptation, cross-validation of the Turkish diabetes quality-of-life (DQOL) measure. Quality of Life Research, 16, 873–879.
Zimmet, P., Alberti, K. G., & Shaw, J. (2001). Global and societal implications of the diabetes epidemic. Nature, 414, 782–787.
Acknowledgement
The authors have no conflicts of interest that are directly relevant to the content of this article.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Bhatt, J.K., Thomas, S. & Nanjan, M.J. Health Outcome Measures for Diabetes Mellitus: A Review. Applied Research Quality Life 7, 413–443 (2012). https://doi.org/10.1007/s11482-012-9168-8
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11482-012-9168-8